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This document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exova's Intranet.
SOP No. 120 Rev 7



1.0 SUMMARY

Below are general descriptions of the duties, responsibilities, authorizations, and training
required for various employment positions. These positions correlate with Exova titles as shown
in Table 1 below. Job responsibilities should be considered cumulative, e.g. a Department
Manager has the responsibilities of subordinate positions as well as those particular to their
position. As needed, personnel may also be assigned specific duties which have not been listed
here but which are consistent with their education, experience and/or training.




                                                                                                          d
Exova procedures detail the employee responsible for performing specific tasks. In accordance




                                                                                      te
with normal management practice, it is acceptable for the designated person to delegate the
actual performance of the task to another individual with the appropriate combination of




                                                                                    in
education, training, or experience to perform that function. However, the responsibility for
ensuring that the task is carried out cannot be delegated.




                                                                                  Pr
2.0 RESPONSIBLE PERSONS



                                                               n
The General Manager is responsible for this SOP. Annual employee training on this document is
                                                             he
required.
                                                     W

3.0 JOB DESCRIPTIONS
                                           d


Where educational requirements are stated, twice the work experience in the associated field
may suffice. For example, 8 years of experience in an analytical chemistry lab may satisfy the
                                 lle



requirement for a 4 year B.S. degree.
                         ro




   3.1 Assistant
                t




       3.1.1    Administrative Assistant
             on




                High School graduation required but no specific prior experience required.
     nc




                Performs non-technical tasks, including support of business functions such as
                invoicing and generation of purchase orders under the direct supervision of the
U




                Office Manager.

       3.1.2    Client Services Assistant

                High School graduation required but no specific prior experience required.
                Prepares and distributes laboratory reports for review and provides administrative
                support to the department under the direct supervision of the Client Services
                Director.



                                                       Page 2 of 10
       This document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exova's Intranet.
SOP No. 120 Rev 7



      3.1.3    Sample Assistant

               High School graduation required but no specific prior experience required.
               Supports sample receipt and disposal functions. Reports to Sample Coordinator.

      3.1.4    QA Assistant

               High School graduation required but no specific prior experience required.
               Assists in documentation control and supports quality systems, including reagent




                                                                                                         d
               and materials receipt under the direct supervision of the HSEQ Officer or QA




                                                                                     te
               Coordinator.




                                                                                   in
  3.2 Technician




                                                                                 Pr
      3.2.1    Sample Preparation or Extraction Technician

               High School graduation required but no specific prior experience required.



                                                              n
               Performs routine equipment calibration verifications and prepares samples,
               reagents, and standards for analysis with associated documentation under the
                                                            he
               direct supervision of the Supervisor or Department Manager. Is authorized to
               perform peer review of documentation.
                                                    W

      3.2.2    Sample Receptionist
                                          d


               High School graduation required but no specific prior experience required.
               Receives and disposes of samples and performs associated documentation and
                                lle



               data entry under the direct supervision of the Sample Coordinator.
                        ro




  3.3 Technologist
               t




      3.3.1    IT/IS Assistant
            on




               B.S. in a scientific discipline and two years computer system maintenance
    nc




               experience. Assists with maintaining hardware and software used by the company
               and performing software and spreadsheet validations. May assist with network
U




               backups and software development. Trains employees on computer operations
               and provides technical support. Reports to the IT/IS Department Manager.

      3.3.2    Facilities Technologist

               High School graduation required. Five years experience in routine facilities
               support including HVAC, minor electrical/cable, pest control, plumbing (water
               and gas), project management, and any other facility requirements. Performs
               associated documentation of activities.


                                                      Page 3 of 10
      This document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exova's Intranet.
SOP No. 120 Rev 7



     3.3.3     Client Services Representative

               B.S. Degree with two years experience in the analytical chemistry industry.
               Organizes and directs work on projects through other managers and Group
               Leaders, handles client inquiries, prepares proposals and bids, and communicates
               results to clients as authorized by the Department Manager or their designee.
               Reports to Client Services Director or General Manager.

     3.3.4     QA Chemist, Data Reviewer




                                                                                                         d
                                                                                     te
               B.S. in a scientific discipline, preferably chemistry, with two years experience as
               a chemist. Performs data package QA review, laboratory investigations including




                                                                                   in
               root cause analysis and corrective/preventive actions, reviews and approves retest
               and reanalysis forms, and other quality system documentation. Participates in




                                                                                 Pr
               process, system, and data internal audits and assists with third-party audits.
               Reports to the HSEQ Officer.




                                                              n
     3.3.5     QA Senior Chemist, Data Reviewer             he
               B.S. in a scientific discipline, preferably chemistry, with five years experience as
               a chemist and two years experience in quality assurance. Performs data package
                                                    W
               QA review, performs and closes laboratory investigations, reviews and approves
               retest and reanalysis forms and other documentation. Leads process, system, and
               data internal audits and assists with third-party audits. Trains employees in
                                          d


               quality systems. Communicates with clients and auditors regarding data and
               quality systems. Reports to the HSEQ Officer.
                                lle




  3.4 Analyst
                        ro




     3.4.1     Chemist
               t
            on




               B.S. in a scientific discipline, preferably chemistry, with 0-2 years experience.
               Performs routine analyses and associated documentation, may perform routine
    nc




               equipment maintenance, prepares data packages for review, notifies supervisor of
               Out-of-Specification, laboratory incident, and QC Action events. Is authorized to
U




               perform peer review of documentation. Reports to, and is closely supervised by,
               an Analytical Chemist or Department Manager.




                                                      Page 4 of 10
      This document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exova's Intranet.
SOP No. 120 Rev 7

     3.4.2     Senior Chemist

               B.S. in the sciences and five years relevant experience. Trained to perform and
               supervise a variety of routine and some non-routine tasks, evaluates and develops
               new methods, authors and approves SOP’s, performs non-routine instrument
               repair, prepares and reviews data packages, is authorized to give opinions and
               interpretations in final reports when clearly identified as such, contacts clients
               with results or for resolution of problems, approves investigations of
               Out-of-Specification results, may be assigned to sign final reports, helps train
               other chemists, requisitions routine and non-routine supplies and equipment.




                                                                                                         d
               Reports to Department Manager, General Manager, or Technical Director.




                                                                                     te
     3.4.3     Senior Staff Chemist




                                                                                   in
               B.S. and 10 years experience. Performs routine and non-routine tasks and




                                                                                 Pr
               analyses, develops new methods, performs complex instrument repairs, prepares
               and reviews data packages and narratives, is authorized to give opinions and
               interpretations in final reports when clearly identified as such, works with clients



                                                              n
               on technical issues, trains other chemists, requisitions non-routine supplies and
               equipment. Reports to Department Manager, General Manager, or Technical
                                                            he
               Director.
                                                    W
     3.4.4 Principle Investigator

               Sr. Chemist or above who is assigned by the Technical Director or HSEQ Officer
                                          d


               to projects which must comply with Good Laboratory Practices (GLP).
               Responsible for overall study from a technical standpoint, including conducting
                                lle



               the study according to protocol, interpreting the results, documenting and
               verifying results, obtaining approval of protocol changes, selecting corrective
                        ro




               action, compliance of study with GLP, and archival of all raw data,
               documentation, protocol, specimens, and reports at the close of the study. Reports
               t




               to Study Director for the scope of the project; the Study Director is usually
            on




               assigned by the client, external to this laboratory.
    nc




     3.4.5     Senior Scientist
U




               Ph.D. and 20 years experience. Prepares method validation protocols, performs
               routine and non-routine analyses, develops new methods, performs complex
               instrument repairs, prepares and reviews data packages and narratives, is
               authorized to give opinions and interpretations in final reports when clearly
               identified as such, works with clients on technical issues, trains others,
               requisitions non-routine supplies and equipment. Reports to General Manager or
               Technical Director.




                                                      Page 5 of 10
      This document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exova's Intranet.
SOP No. 120 Rev 7



  3.5 Coordinator

     3.5.1     Sample Coordinator

               High School graduation required. Reviews incoming Analytical Request Forms
               and other sample receipt documentation. Prepares and issues Job Sheets to
               Department Managers. Supervises sample receipt and disposal and is authorized
               to contact clients regarding execution of contracted services.




                                                                                                         d
     3.5.2     QA Coordinator




                                                                                     te
               Sr. Chemist or above who maintains QA databases, including the equipment




                                                                                   in
               qualification schedule; prepares and reviews QA trend reports including the
               annual management review; may work with clients and Managers to develop QA




                                                                                 Pr
               project plans; assists the Technical Director and HSEQ Officer in maintaining
               SOP’s and the QA Manual. Hosts third-party audits. Reports to HSEQ Officer.




                                                              n
     3.5.3     Health, Safety and Environmental (HSE) Coordinator
                                                            he
               Sr. Chemist or above who assists chemists in safely handling chemicals and other
               hazards, coordinates hazardous waste disposal, conducts safety meetings and
                                                    W
               safety training, and assists in maintaining the Safety Manual. Requires current
               HAZWOPR supervisor level certification. Heads the Joint Health and Safety
               Committee. Reports to the HSEQ Officer.
                                          d


     3.5.4     IT/IS Coordinator
                                lle




               B.S. in a scientific discipline and two years laboratory computer system
                        ro




               experience. Responsible for maintaining hardware and software used by
               analytical instrumentation to include the network, spreadsheet and word
               t




               processing software, printers and workstations. Responsible for maintaining
            on




               network backups and SOP’s associated with the computers and network. May
               work on software development and validation projects. Trains employees on
    nc




               computer operations and provides technical support. Reports to the IT/IS
               Department Manager.
U




  3.6 Department Manager

     3.6.1     Client Services Director

               B.S in a business or scientific discipline with 10 years lab management
               experience. Responsible for sample receiving, sample control, report generation
               and distribution, client communication, and marketing literature. Reports to
               General Manager.


                                                      Page 6 of 10
      This document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exova's Intranet.
SOP No. 120 Rev 7

     3.6.2     Group Leader

               Sr. Chemist or above who is additionally responsible for all SOP’s for their
               group; ensures that the analysts have read, understood, and signed-off on SOP’s,
               and that analysts have the training, information, qualification, and resources to
               perform their assignments; assigns tasks and schedules to those in group; enforces
               safety and QA policies in group; maintains equipment and calls contractor for
               repairs when needed; maintains outstanding job lists and attends staff meetings to
               assess turnaround times; reviews and signs data packages; reviews instrument and
               maintenance logs; approves the use of Out-of-Control Limits data; performs




                                                                                                         d
               out-of-specification and other laboratory investigations; approves overtime and




                                                                                     te
               time-off requests; works with managers and directors to meet project schedules
               and goals; administrates personnel policies within group, and conducts




                                                                                   in
               performance and salary reviews for group; approves requisitions of supplies up to
               $1000. Reports to General Manager or Technical Director.




                                                                                 Pr
     3.6.3 Business Development Executive




                                                              n
               Two years sales experience in the services industry who develops and markets
               services through presentations and visits to clients. Reports to General Manager.
                                                            he
     3.6.4     IT/IS Department Manager
                                                    W

               B.S. in a scientific discipline and two years computer system maintenance
               experience. Responsible for maintaining hardware and software used by the
                                          d


               company to include the network, Visual FoxPro Job Tracking, spreadsheet and
               word processing software, printers and workstations. Responsible for maintaining
                                lle



               network backups and SOP’s associated with the computers and network. May
               work on software development and validation projects. Trains employees on
                        ro




               computer operations and provides technical support. Reports to the corporate
               IT/IS Director.
               t
            on




     3.6.5 Office Manager
    nc




               B.S. degree and 10 years experience in the laboratory services industry.
               Responsible for administration of the accounts receivable and payable,
U




               purchasing, capital expenditures, and human resources.




                                                      Page 7 of 10
      This document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exova's Intranet.
SOP No. 120 Rev 7



  3.7 Senior Management

     3.7.1 HSEQ Officer

               Sr. Chemist or above with three or more years auditing experience in the
               pharmaceutical, biologics, or medical device industry; training in ISO/IEC 17025;
               training in statistics; and at least one year of non-academic analytical chemistry
               experience. Ensures that the management system related to quality is
               implemented and followed at all times; maintains the QA Manual; works with




                                                                                                         d
               other managers to train personnel; manages complaint and laboratory




                                                                                     te
               investigations, training and employee qualification, vendor qualification,
               equipment qualifications, and change controls; supports sales and marketing;




                                                                                   in
               assists the Technical Director in maintaining SOP’s; and heads the Quality
               Assurance Unit for GLP and GMP projects. Approves Quality Agreements with




                                                                                 Pr
               clients and responses to client and regulatory audits. Coomunicates results of
               internal and third-party audits to Management. In conjunction with the General
               Manager, establish quality management objectives for the continual improvement



                                                              n
               of the management system which are reviewed during management review.
               Manages the safety training and monitoring program and maintains the Safety
                                                            he
               Manual. Reports to General Manager and the Corporate HSEQ Director.
                                                    W
     3.7.2 Technical Director

               Sr. Staff Chemist who has a working knowledge of all technical aspects of the
                                          d


               laboratory. Responsible for the quality of data, including technical compliance
               with ISO/IEC 17025, GMP/GLP, and other applicable regulatory standards;
                                lle



               SOP’s for laboratory operations and technical training of personnel; prepares
               method validation protocols; conducts performance and salary reviews of
                        ro




               Managers with the General Manager; approves use of Out-of-Control Limits data;
               closes complaint and laboratory investigations; keeps the lab current on technical
               t




               issues; evaluates and develops new methods; conducts training classes; prepares
            on




               technical presentations and papers; first signature on reports (unless not
               available); knowledgeable in all methods required by regulations. Three years or
    nc




               more non-academic analytical laboratory experience in metals analysis is
               required. Reports to General Manager.
U




                                                      Page 8 of 10
      This document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exova's Intranet.
SOP No. 120 Rev 7



  3.8 Executive Management - General Manager

     Sr. Chemist or above who is responsible for scheduling and administration of the entire
     laboratory, provides final approval of time off and overtime, conducts performance and
     salary reviews of Managers, works with corporate on developing and implementing
     personnel policies, supports marketing and sales personnel, approves proposals,
     contracts, and bids, conducts training, approves vendors, recommends equipment
     purchases, approves requisitions up to $10,000, maintains operational SOP’s. In
     conjunction with the HSEQ Officer, is responsible for implementation, maintenance and




                                                                                                         d
     improvement of the management system, including compliance with ISO/IEC 17025,




                                                                                     te
     GMP/GLP, OSHA, and other applicable regulatory standards. Ensure that laboratory
     management and personnel are free from any undue internal and external commercial,




                                                                                   in
     financial or other pressures and influences that may adversely affect the quality of their
     work. Closes complaint investigations, maintains certifications and accreditations, and




                                                                                 Pr
     approves the QA and Safety Manuals. Approves responses to client and regulatory
     audits; reviews internal audits, management reviews, and trend reports. Is responsible for
     profitability of the business, marketing, and short and long term planning; prepares large



                                                              n
     bids and proposals. Reports to the Executive Vice-President of the Health Services and
     Analytical Division of Exova.
                                                            he
                                                    W
                                          d
                                lle
               t        ro
            on
    nc
U




                                                      Page 9 of 10
      This document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exova's Intranet.
SOP No. 120 Rev 7

                        Table 1. Correlation of Exova Titles and Job Function

               Exova Position                                       Exova Functional Title

               Assistant                                            Administrative Assistant
                                                                    QA Assistant
                                                                    Sample Assistant
                                                                    Client Services Assistant

               Technician                                           Sample Prep Technician




                                                                                                         d
                                                                    Extraction Technician




                                                                                     te
                                                                    Sample Receptionist




                                                                                   in
               Technologist                                         Facilities Technologist
                                                                    IT/IS Assistant




                                                                                 Pr
                                                                    Client Services Representative
                                                                    QA Senior Chemist - Data Reviewer
                                                                    QA Chemist - Data Reviewer



                                                              n
               Analyst                                              Chemist
                                                            he
                                                                    Senior Chemist
                                                                    Senior Staff Chemist
                                                    W
                                                                    Principle Investigator
                                                                    Senior Scientist
                                          d


               Coordinator                                          QA Coordinator
                                                                    IT/IS Coordinator
                                lle



                                                                    HSE Coordinator
                                                                    Sample Coordinator
                        ro




               Department Manager                                   GC/GCMS Group Leader
               t




                                                                    Inorganics Group Leader
            on




                                                                    IC/LC Group Leader
                                                                    Wet Chemistry Group Leader
    nc




                                                                    Spectroscopy Group Leader
                                                                    IT/IS Department Manager
U




                                                                    Client Services Director
                                                                    Business Development Executive
                                                                    Office Manager

               Senior Management                                    HSEQ Officer
                                                                    Technical Director

               Executive Management                                 General Manager



                                                     Page 10 of 10
      This document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exova's Intranet.

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120v7 roles and responsibilities

  • 1. d te in Pr n he W d lle t ro on nc U This document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exova's Intranet.
  • 2. SOP No. 120 Rev 7 1.0 SUMMARY Below are general descriptions of the duties, responsibilities, authorizations, and training required for various employment positions. These positions correlate with Exova titles as shown in Table 1 below. Job responsibilities should be considered cumulative, e.g. a Department Manager has the responsibilities of subordinate positions as well as those particular to their position. As needed, personnel may also be assigned specific duties which have not been listed here but which are consistent with their education, experience and/or training. d Exova procedures detail the employee responsible for performing specific tasks. In accordance te with normal management practice, it is acceptable for the designated person to delegate the actual performance of the task to another individual with the appropriate combination of in education, training, or experience to perform that function. However, the responsibility for ensuring that the task is carried out cannot be delegated. Pr 2.0 RESPONSIBLE PERSONS n The General Manager is responsible for this SOP. Annual employee training on this document is he required. W 3.0 JOB DESCRIPTIONS d Where educational requirements are stated, twice the work experience in the associated field may suffice. For example, 8 years of experience in an analytical chemistry lab may satisfy the lle requirement for a 4 year B.S. degree. ro 3.1 Assistant t 3.1.1 Administrative Assistant on High School graduation required but no specific prior experience required. nc Performs non-technical tasks, including support of business functions such as invoicing and generation of purchase orders under the direct supervision of the U Office Manager. 3.1.2 Client Services Assistant High School graduation required but no specific prior experience required. Prepares and distributes laboratory reports for review and provides administrative support to the department under the direct supervision of the Client Services Director. Page 2 of 10 This document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exova's Intranet.
  • 3. SOP No. 120 Rev 7 3.1.3 Sample Assistant High School graduation required but no specific prior experience required. Supports sample receipt and disposal functions. Reports to Sample Coordinator. 3.1.4 QA Assistant High School graduation required but no specific prior experience required. Assists in documentation control and supports quality systems, including reagent d and materials receipt under the direct supervision of the HSEQ Officer or QA te Coordinator. in 3.2 Technician Pr 3.2.1 Sample Preparation or Extraction Technician High School graduation required but no specific prior experience required. n Performs routine equipment calibration verifications and prepares samples, reagents, and standards for analysis with associated documentation under the he direct supervision of the Supervisor or Department Manager. Is authorized to perform peer review of documentation. W 3.2.2 Sample Receptionist d High School graduation required but no specific prior experience required. Receives and disposes of samples and performs associated documentation and lle data entry under the direct supervision of the Sample Coordinator. ro 3.3 Technologist t 3.3.1 IT/IS Assistant on B.S. in a scientific discipline and two years computer system maintenance nc experience. Assists with maintaining hardware and software used by the company and performing software and spreadsheet validations. May assist with network U backups and software development. Trains employees on computer operations and provides technical support. Reports to the IT/IS Department Manager. 3.3.2 Facilities Technologist High School graduation required. Five years experience in routine facilities support including HVAC, minor electrical/cable, pest control, plumbing (water and gas), project management, and any other facility requirements. Performs associated documentation of activities. Page 3 of 10 This document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exova's Intranet.
  • 4. SOP No. 120 Rev 7 3.3.3 Client Services Representative B.S. Degree with two years experience in the analytical chemistry industry. Organizes and directs work on projects through other managers and Group Leaders, handles client inquiries, prepares proposals and bids, and communicates results to clients as authorized by the Department Manager or their designee. Reports to Client Services Director or General Manager. 3.3.4 QA Chemist, Data Reviewer d te B.S. in a scientific discipline, preferably chemistry, with two years experience as a chemist. Performs data package QA review, laboratory investigations including in root cause analysis and corrective/preventive actions, reviews and approves retest and reanalysis forms, and other quality system documentation. Participates in Pr process, system, and data internal audits and assists with third-party audits. Reports to the HSEQ Officer. n 3.3.5 QA Senior Chemist, Data Reviewer he B.S. in a scientific discipline, preferably chemistry, with five years experience as a chemist and two years experience in quality assurance. Performs data package W QA review, performs and closes laboratory investigations, reviews and approves retest and reanalysis forms and other documentation. Leads process, system, and data internal audits and assists with third-party audits. Trains employees in d quality systems. Communicates with clients and auditors regarding data and quality systems. Reports to the HSEQ Officer. lle 3.4 Analyst ro 3.4.1 Chemist t on B.S. in a scientific discipline, preferably chemistry, with 0-2 years experience. Performs routine analyses and associated documentation, may perform routine nc equipment maintenance, prepares data packages for review, notifies supervisor of Out-of-Specification, laboratory incident, and QC Action events. Is authorized to U perform peer review of documentation. Reports to, and is closely supervised by, an Analytical Chemist or Department Manager. Page 4 of 10 This document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exova's Intranet.
  • 5. SOP No. 120 Rev 7 3.4.2 Senior Chemist B.S. in the sciences and five years relevant experience. Trained to perform and supervise a variety of routine and some non-routine tasks, evaluates and develops new methods, authors and approves SOP’s, performs non-routine instrument repair, prepares and reviews data packages, is authorized to give opinions and interpretations in final reports when clearly identified as such, contacts clients with results or for resolution of problems, approves investigations of Out-of-Specification results, may be assigned to sign final reports, helps train other chemists, requisitions routine and non-routine supplies and equipment. d Reports to Department Manager, General Manager, or Technical Director. te 3.4.3 Senior Staff Chemist in B.S. and 10 years experience. Performs routine and non-routine tasks and Pr analyses, develops new methods, performs complex instrument repairs, prepares and reviews data packages and narratives, is authorized to give opinions and interpretations in final reports when clearly identified as such, works with clients n on technical issues, trains other chemists, requisitions non-routine supplies and equipment. Reports to Department Manager, General Manager, or Technical he Director. W 3.4.4 Principle Investigator Sr. Chemist or above who is assigned by the Technical Director or HSEQ Officer d to projects which must comply with Good Laboratory Practices (GLP). Responsible for overall study from a technical standpoint, including conducting lle the study according to protocol, interpreting the results, documenting and verifying results, obtaining approval of protocol changes, selecting corrective ro action, compliance of study with GLP, and archival of all raw data, documentation, protocol, specimens, and reports at the close of the study. Reports t to Study Director for the scope of the project; the Study Director is usually on assigned by the client, external to this laboratory. nc 3.4.5 Senior Scientist U Ph.D. and 20 years experience. Prepares method validation protocols, performs routine and non-routine analyses, develops new methods, performs complex instrument repairs, prepares and reviews data packages and narratives, is authorized to give opinions and interpretations in final reports when clearly identified as such, works with clients on technical issues, trains others, requisitions non-routine supplies and equipment. Reports to General Manager or Technical Director. Page 5 of 10 This document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exova's Intranet.
  • 6. SOP No. 120 Rev 7 3.5 Coordinator 3.5.1 Sample Coordinator High School graduation required. Reviews incoming Analytical Request Forms and other sample receipt documentation. Prepares and issues Job Sheets to Department Managers. Supervises sample receipt and disposal and is authorized to contact clients regarding execution of contracted services. d 3.5.2 QA Coordinator te Sr. Chemist or above who maintains QA databases, including the equipment in qualification schedule; prepares and reviews QA trend reports including the annual management review; may work with clients and Managers to develop QA Pr project plans; assists the Technical Director and HSEQ Officer in maintaining SOP’s and the QA Manual. Hosts third-party audits. Reports to HSEQ Officer. n 3.5.3 Health, Safety and Environmental (HSE) Coordinator he Sr. Chemist or above who assists chemists in safely handling chemicals and other hazards, coordinates hazardous waste disposal, conducts safety meetings and W safety training, and assists in maintaining the Safety Manual. Requires current HAZWOPR supervisor level certification. Heads the Joint Health and Safety Committee. Reports to the HSEQ Officer. d 3.5.4 IT/IS Coordinator lle B.S. in a scientific discipline and two years laboratory computer system ro experience. Responsible for maintaining hardware and software used by analytical instrumentation to include the network, spreadsheet and word t processing software, printers and workstations. Responsible for maintaining on network backups and SOP’s associated with the computers and network. May work on software development and validation projects. Trains employees on nc computer operations and provides technical support. Reports to the IT/IS Department Manager. U 3.6 Department Manager 3.6.1 Client Services Director B.S in a business or scientific discipline with 10 years lab management experience. Responsible for sample receiving, sample control, report generation and distribution, client communication, and marketing literature. Reports to General Manager. Page 6 of 10 This document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exova's Intranet.
  • 7. SOP No. 120 Rev 7 3.6.2 Group Leader Sr. Chemist or above who is additionally responsible for all SOP’s for their group; ensures that the analysts have read, understood, and signed-off on SOP’s, and that analysts have the training, information, qualification, and resources to perform their assignments; assigns tasks and schedules to those in group; enforces safety and QA policies in group; maintains equipment and calls contractor for repairs when needed; maintains outstanding job lists and attends staff meetings to assess turnaround times; reviews and signs data packages; reviews instrument and maintenance logs; approves the use of Out-of-Control Limits data; performs d out-of-specification and other laboratory investigations; approves overtime and te time-off requests; works with managers and directors to meet project schedules and goals; administrates personnel policies within group, and conducts in performance and salary reviews for group; approves requisitions of supplies up to $1000. Reports to General Manager or Technical Director. Pr 3.6.3 Business Development Executive n Two years sales experience in the services industry who develops and markets services through presentations and visits to clients. Reports to General Manager. he 3.6.4 IT/IS Department Manager W B.S. in a scientific discipline and two years computer system maintenance experience. Responsible for maintaining hardware and software used by the d company to include the network, Visual FoxPro Job Tracking, spreadsheet and word processing software, printers and workstations. Responsible for maintaining lle network backups and SOP’s associated with the computers and network. May work on software development and validation projects. Trains employees on ro computer operations and provides technical support. Reports to the corporate IT/IS Director. t on 3.6.5 Office Manager nc B.S. degree and 10 years experience in the laboratory services industry. Responsible for administration of the accounts receivable and payable, U purchasing, capital expenditures, and human resources. Page 7 of 10 This document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exova's Intranet.
  • 8. SOP No. 120 Rev 7 3.7 Senior Management 3.7.1 HSEQ Officer Sr. Chemist or above with three or more years auditing experience in the pharmaceutical, biologics, or medical device industry; training in ISO/IEC 17025; training in statistics; and at least one year of non-academic analytical chemistry experience. Ensures that the management system related to quality is implemented and followed at all times; maintains the QA Manual; works with d other managers to train personnel; manages complaint and laboratory te investigations, training and employee qualification, vendor qualification, equipment qualifications, and change controls; supports sales and marketing; in assists the Technical Director in maintaining SOP’s; and heads the Quality Assurance Unit for GLP and GMP projects. Approves Quality Agreements with Pr clients and responses to client and regulatory audits. Coomunicates results of internal and third-party audits to Management. In conjunction with the General Manager, establish quality management objectives for the continual improvement n of the management system which are reviewed during management review. Manages the safety training and monitoring program and maintains the Safety he Manual. Reports to General Manager and the Corporate HSEQ Director. W 3.7.2 Technical Director Sr. Staff Chemist who has a working knowledge of all technical aspects of the d laboratory. Responsible for the quality of data, including technical compliance with ISO/IEC 17025, GMP/GLP, and other applicable regulatory standards; lle SOP’s for laboratory operations and technical training of personnel; prepares method validation protocols; conducts performance and salary reviews of ro Managers with the General Manager; approves use of Out-of-Control Limits data; closes complaint and laboratory investigations; keeps the lab current on technical t issues; evaluates and develops new methods; conducts training classes; prepares on technical presentations and papers; first signature on reports (unless not available); knowledgeable in all methods required by regulations. Three years or nc more non-academic analytical laboratory experience in metals analysis is required. Reports to General Manager. U Page 8 of 10 This document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exova's Intranet.
  • 9. SOP No. 120 Rev 7 3.8 Executive Management - General Manager Sr. Chemist or above who is responsible for scheduling and administration of the entire laboratory, provides final approval of time off and overtime, conducts performance and salary reviews of Managers, works with corporate on developing and implementing personnel policies, supports marketing and sales personnel, approves proposals, contracts, and bids, conducts training, approves vendors, recommends equipment purchases, approves requisitions up to $10,000, maintains operational SOP’s. In conjunction with the HSEQ Officer, is responsible for implementation, maintenance and d improvement of the management system, including compliance with ISO/IEC 17025, te GMP/GLP, OSHA, and other applicable regulatory standards. Ensure that laboratory management and personnel are free from any undue internal and external commercial, in financial or other pressures and influences that may adversely affect the quality of their work. Closes complaint investigations, maintains certifications and accreditations, and Pr approves the QA and Safety Manuals. Approves responses to client and regulatory audits; reviews internal audits, management reviews, and trend reports. Is responsible for profitability of the business, marketing, and short and long term planning; prepares large n bids and proposals. Reports to the Executive Vice-President of the Health Services and Analytical Division of Exova. he W d lle t ro on nc U Page 9 of 10 This document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exova's Intranet.
  • 10. SOP No. 120 Rev 7 Table 1. Correlation of Exova Titles and Job Function Exova Position Exova Functional Title Assistant Administrative Assistant QA Assistant Sample Assistant Client Services Assistant Technician Sample Prep Technician d Extraction Technician te Sample Receptionist in Technologist Facilities Technologist IT/IS Assistant Pr Client Services Representative QA Senior Chemist - Data Reviewer QA Chemist - Data Reviewer n Analyst Chemist he Senior Chemist Senior Staff Chemist W Principle Investigator Senior Scientist d Coordinator QA Coordinator IT/IS Coordinator lle HSE Coordinator Sample Coordinator ro Department Manager GC/GCMS Group Leader t Inorganics Group Leader on IC/LC Group Leader Wet Chemistry Group Leader nc Spectroscopy Group Leader IT/IS Department Manager U Client Services Director Business Development Executive Office Manager Senior Management HSEQ Officer Technical Director Executive Management General Manager Page 10 of 10 This document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exova's Intranet.